FDA Orphan Product Designation and Grant Workshop
We are planning to reschedule the Orphan Products Designation and Grants Workshop. This workshop was originally scheduled for October 4, 2013
We will post information regarding the date, time and location as soon as we have it.
Registration has closed for the FDA/EMA Orphan Products Designation and Grant Workshop at the FDA White Oak Campus in Silver Spring, MD, on Friday, October 4, 2013, 8:30 am – 4:00 pm.
For workshop information and agenda - Click Here
Workshop Description- This one-day workshop is designed to provide valuable information about the EMA and FDA Orphan Drug Designation programs, the FDA Humanitarian Use Device (HUD) Designation program, the FDA Orphan Products Grant program to participants representing pharmaceutical, biotechnology, and device companies, as well as to academics.
The afternoon session will not be webcast and provides an opportunity for appropriately registered participants to have one-on-one meetings with FDA staff members onsite, to discuss the specifics on how to apply for an orphan product grant, a HUD designation, or orphan drug designation. It also provides for videoconference sessions with EMA staff representatives on EMA orphan drug designation.